Impact of Breakfast Composition on Glycemic and Incretin Responses in Individuals With Type 2 Diabetes

University of Missouri (MU)

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: High carb breakfast; Other: High protein breakfast

Study type: Interventional

Funder types: Other

Identifiers

NCT02180646

b2d2-01

Details and patient eligibility

About

This study examined the effect of a high protein or high carbohydrate breakfast on the glucose and insulin response following the breakfast meal, as well as the subsequent response following the lunch meal.

Full description

Twelve habitual breakfast consumers with type 2 diabetes (T2D) were recruited for the study. They completed two, 7-day conditions in random order with a minimum of a 7-day washout period between study days. They consumed either a high protein (PRO) or high carbohydrate (CHO) breakfast for 6 days of acclimatization, and on the seventh day, they reported to the lab at 0700 hours following a ~12 hour overnight fast and underwent forearm catheterization before a baseline blood draw. The participants consumed the respective breakfast at ~0730 hours. Four hours post-breakfast, subjects consumed a standard lunch meal. Blood samples were taken continuously throughout the 8-hour test day.

Enrollment: 12 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 21-55 y of age
• body mass index (BMI) between 30-40 kg/m2
• weight stable for the prior 6 months
• non-smokers
• minimal alcohol consumption (< 2 drinks per day)
• type 2 diabetic (diagnosed ≥ 2 y)
• a fasting glucose level above 120 mg/dL
• HbA1c between 6.5-9.0%

Exclusion criteria

• insulin
• β-blockers
• GLP-1 agonists (e.g. exenatide)
• dipeptidyl peptidase (DPP) inhibitors
• weight loss
• using weight-loss medications
• pregnant or lactating

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

High Carb then High Protein Breakfast

Active Comparator group

Description:

A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) followed by a 7-day washout period, and then 7 days of eating a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat).

Treatment:

Other: High carb breakfast

Other: High protein breakfast

High Protein then High Carb Breakfast

Active Comparator group

Description:

A high protein breakfast - 500 kcal followed by a 7-day washout period, and then 7 days of eating a high carbohydrate breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)

Treatment:

Other: High carb breakfast

Other: High protein breakfast